19/6/2019 ASTM F 1886-1998(Reapproved 2004) - 百度文库

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ASTM F 1886-1998 (Reapproved 2004)

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ASTM D95
6页
Designation: F 1886 – 98 (Reapproved 2004)
ASTM F963
20

ASTM B117
Standard Test Method for 10

Determining Integrity of Seals for Medical Packaging by astm a139

Visual Inspection1 6页

This standard is issued under the fixed designation F 1886; the number immediately following the designation indicates the year of
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original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
ASTM E186-
3页
ASTM F1929
1. Scope 3.1.2 sterile package integrity,
integrity, n—property of the package
3页
1.1 This test method covers the determination of channels in seal and material, which ensures that it presents a microbial
the package seal down to a width of 75 µm (0.003 in.) with a barrier. (see also Terminology F 17, microbiological package ASTM F1929
60–100 % probability (see Section 8). integrity).
integrity). 3页

1.1.1 The
package seals ability to dependent
is highly visually detect
on the channel defects the
size of channel, in
degree of contrast from sealed and unsealed areas, the amount
and type of adhesive between the two package layers, reflect-
ing light angle, types of material used, the use of magnification,
and the inspector’s level of training and experience.
1.2 This test method is applicable to flexible and rigid
packages with at least one transparent side so that the seal area
may1.3beThe
clearly viewed.
values stated in SI units are to be regarded as the
standard. The values given in parentheses are for information
only.
1.4 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
priate safety and health practices and determine the applica-
bility of regulatory limitations prior to use.
F1929染料渗
4. Summary of Test Method
3页
4.1 This test method provides a qualitative (accept/reject)
visual inspection method to evaluate the appearance character- ASTM D882-
istics of unopened, intact seals in order to determine the 9页
presence of defects that may affect the integrity of the package.
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5. Significance and Use
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5.1 Seal attributes can be linked directly to a number of
variables in process parameters, equipment, or material, as well
as environmental (room temperature and relative humidity).
Visual seal characteristics and defects can provide evidence of
sterile package integrity and production sealing problems.
5.2 Visual seal defects often will be the first indication of
heat sealing process variation. They also will indicate a lack of,
or potential compromise to, package integrity after physical
package performance testing.

2. Referenced Documents 6. Apparatus

2.1 ASTM Standards: 2 6.1 Illuminant,
Illuminant, lighting arrangements to give about 540
F 17 Terminology Relating to Flexible Barrier Materials lumens/m2 (50 fc) of white light or daylight on the specimens.
6.2 Indelible Marking Pen.
3. Terminology
7. Procedure
3.1 Definitions of Terms Specific to This Standard:
3.1.1 channel,
channel, n—any unimpaired pathway across the entire 7.1 Visual acuity shall be such that the inspection of the seal
width of the intended seal. may be performed at a distance of 30 to 45 cm (12 to 18 in.) 热门
NOTE 1—Magnification devices, such as eyeloops, may be used as an
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analytical tool to characterize identified seal defects.
1
This test method is under the jurisdiction of ASTM Committee F02 on Flexible
7.2 Inspect the entire sealed area of the package for com-
Barrier Materials and is the direct responsibility of Subcommittee F02.60 on
Medical Device Packaging. pleteness and uniformity. 客户端
Current edition approved June 1, 2004. Published June 2004. Originally
approved in 1998. Last previous edition approved in 1998 as F 1886 – 98.
NOTE 2—Different package sizes and shapes may require differing
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or lengths of time to adequately inspect the entire seal perimeter. Any time
requirement associated with visual inspection should allow for complete 极速收纳
contact ASTM
Standards Customer
volume Service
information, at service@astm.org.
refer For Annual
to the standard’s Document Book ofpage
Summary ASTMon seal inspection without taking too much time to intensely focus on any
the ASTM website. given area.

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19/6/2019 ASTM F 1886-1998(Reapproved 2004) - 百度文库

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NOTE 3—Some packaging materials and adhesives may fluoresce under probability of a correct evaluation. A statistical analysis of the
ultraviolet light. Viewing the seal area in a UV light box will enhance the data by means of a contingency table show significant differ-
sealed-to-unsealed
tion. area contrast, and provide for easier defect identifica- ences between all factors presented in the tables at a confidence
level of better than 99 %. The results are presented in Tables
7.3 Identify and record any part of the seal where channels 1-4.
appear across the entire seal width. Mark the location of the
channels. TABLE 1 Percent Incorrect by Laboratory
NOTE 4—All other assessed defects (refer to Appendix X1) should be Lab Samples Incorrect Percent (%)
categorized according to user defined accept/reject criteria. Define the Inspected Analysis Incorrect
actions to be taken in the event defects are detected during normal 1 117 0 0.00

production runs. 2
3 117 24
5 20.51
4.27
7.4 Record the number and location of channels identified 4 117 17 14.53
on each package. 5 117 5 4.27
6 117 12 10.26
NOTE 5—If confirmation of channels or incomplete seal areas in 7 117 9 7.69
peelable packages is necessary, hand peel such suspected package 8 117 18 15.38
9 117 26 22.22
completely separating the two material components and inspect the seal
10 117 10 8.55
area of the transferred adhesive for the same incomplete seal attributes as
the unopened package. Care should be taken to ensure a smooth

continuous
Heat peelingbemotion
seals should cooled so
to as not toconditions
ambient cause anybefore
extraneous attributes.
peeling open to TABLE 2 Percent Incorrect by Material
allow for adhesive bonding to the opposite substrate to occur. Samples Incorrect Percent (%)
In some instances, a channel or unsealed area may be observed only Material Inspected Analysis Incorrect
after the package is peeled open. Adhesive transfer is a qualitative Film paper 300 14 4.67
measure of a material’s ability to release the coating rather than conclusive Film TYVEK 300 38 12.67
evidence that the seal has not bee made. It is possible to have continuous PETG/TYVEK 290 59 20.34
Film/film 280 15 5.36
seal integrity but fail to give complete transfer. This is because the coating
may have a stronger affinity for the substrate on which it is coated rather
than the one to which it is sealed. In such cases, an additional physical seal
integrity test may be required to confirm if it is an unsealed area. TABLE 3 Percent Incorrect by Defect Type
Samples Incorrect Percent
3
8. Precision and Bias Defect Type Inspected Analysis (%) Incorrect

8.1 A round robin study was conducted in 1997, which No channels 370 20 5.41
75 µm channel 400 83 20.75
included ten laboratories, four package types, and two different 125 µm channel 400 23 5.75
channel sizes randomly produced with 75 µm (0.003 in.) and
125 µm (0.005 in.) diameter wire. The negative control consists
of the same type packages produced with no channels. The four TABLE 4 Percent Correct by Material and Defect Type

different types of medical device packages are: Samples Correct Percent (%)
8.1.1 Open pouch (5 by 7 in.)—clear film/coated paper; Material Defect Type Inspected Analysis Correct
8.1.2 Open pouch (51⁄4 by 71⁄2 in.)—clear film/uncoated Film/paper none 100 97 97
TYVEK4; 75 µm 100 89 89
125 µm 100 100 100
8.1.3 Sealed rigid blister (81⁄2 by 51⁄4 in.)—blue tinted Film/TYVEK none 100 97 97
blister/coated TYVEK; and, 75 µm 100 69 69
8.1.4 Open end pouch (6 by 81⁄2 in.)—clear film/clear film 125 µm 100 96 96
PETG/TYVEK none 90 88 98
(clear seal). 75 µm 100 60 60

8.2 isThe results of thisanstudy are pass or fail;oftherefore, 125 µM 100 83 83

data binomial with expected average np and the
an Film/film none 80 68 85
75 µm 100 99 99
expected variance of npg where n is the number of samples, p 125 µm 100 98 98
is the probability of an incorrect evaluation, and q is the

9. Keywords
3
Supporting data have been filed at ASTM International Headquarters and may
be obtained by requesting Research Report RR: F02–1013. 9.1 channels; medical packaging; minimum seal width;
4
TYVEK is a trademark of Dupont, Wilmington DE. spotty seals; sterile package integrity; visual seal inspection

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APPENDIX
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X1 VISUAL SEAL APPEARANCE CHARACTERISTICS AND PROBABLE CAUSES
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19/6/2019 ASTM F 1886-1998(Reapproved 2004) - 百度文库
X1. VISUAL SEAL APPEARANCE CHARACTERISTICS AND PROBABLE CAUSES
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X1.1 This appendix will serve to review some of the
common seal appearance characteristics that may occur and
some common reasons for that occurrence. Specifications for
these seal characteristics need to be established by individual
organizations for their specific product and package styles.
Each requirement should be established with appropriate
rationale and necessary supporting documentation.
X1.2 Unsealed Areas—An
Areas—An unsealed area occurs when a
heat seal is never made to the package or when a seal has been
condition often is seen as a transparent or translucent seal
where the material fibers are fused. This may become evident
through an evaluation for pinholes or cracks along the seal.
Another result of oversealing may be a spotty or incomplete
looking seal where, in this case, the heat seal adhesive is
overheated and flows into the porous fiber structure of the
material.
X1.5 Narrow Seals—This
Seals—This may occur either during the
sealing process or as a result of seal creep or partial rupture of

made to misalignment
include a package and of
is later ruptured.
package Causes
to seal to this
bar or problem
platen, mis- the seal under
package due tothe
environmental stresses.
sealing die, skewed Misalignment
packaging of the
components,
alignment of the seal bar or platen to the mating seal surface, bulging product, or misalignment of cutters/slitters during the
foreign matter underneath the seal bar or platen preventing a trimming operation are a few causes that may occur during the
seal, or damage to the seal bar or platen that prevents the seal. sealing process. Seal creep may be a result of the sterilization
There also can be foreign contamination on the packaging process or stressed seals at temperature extremes. Impact also
materials that prevents a seal from being made. Seal rupture may cause the seals to partially rupture. The width of package
can occur due to internal or external forces placed on the seal seals need to be compared to individually defined specification
due to sterilization conditions, weight of product, stressful limits to ensure the package will maintain its integrity through
handling of the package, and so forth. The visual characteris- the expected sterilization, handling, and distribution systems.
tics of a package that has never been sealed versus one that has

been sealed,
depend on theand subsequently
material opened,
substrates beingare very different, and
examined. theX1.6 width of—This
entireChannels—This
Channels is seen seal.
the intended as anCauses
unsealed
forpathway
channelsacross
have
been discussed above in X1.2.
X1.3 Nonhomogeneous or Undersealed Areas—This
Areas—This occurs
when a heat seal is made, and may not have adequate strength X1.7 Wrinkles/Foldovers/Cracks—Foldovers
Wrinkles/Foldovers/Cracks—Foldovers occur when a
due to incorrect process parameters, such as temperature, material is folded over prior to the seal being formed. In some
pressure, or dwell. Insufficient sealing temperature either too situations the seal
complete seal. may situations
In other be of adequate strength
there may not betoadequate
form a
much, too little, or unevenly applied pressure; too short a
process time; or, excessive material thickness variation are strength, and a channel results. Wrinkles and cracks occur after
some of the conditions that may cause seals to appear to be a seal is formed and are caused by the handling of the package.
spotty or mottled. A spotty or mottled appearance may be a Generally, this occurs with flexible substrates. These too can
function of the adhesive properties, as well. This attribute may result in a channel through the entire seal. These types of
be in varying degrees of severity and should be categorized characteristics often are hard to judge by visual inspection
based on appearance and whether sterile package integrity can alone and need to be further evaluated by alternate means such
be maintained. Often it is easier to see this type of defect under as dye penetration.
a magnifying light or UV light box.
X1.8 Tears/Pinholes—These
Tears/Pinholes—These typically occur within the ma-
X1.4 Oversealed
pressure, —A
Areas—A
Areas
or dwell time may combination
cause of to
oversealing toothemuch
pointheat,
that terial
may or substrates,
may not rather
detect than
tearsthe
or seal itself.Further
pinholes. Visual evaluation
inspection
it may cause packaging components to melt and become brittle may be required if visual inspection is not adequate to
and susceptible to cracking. When TYVEK spunbonded poly- determine acceptability. Light box inspection or physical
olefin or a similar porous material is once of the substrates, this package integrity tests may be appropriate.

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